This application claims priority to Italian Application Serial No. M02000A000124 filed Jun. 9, 2000, the disclosure of which is incorporated herein by reference.
The present invention relates to a single-use preassembled medical device for administering at least two drugs in preset proportions to patients.
Preassembled single-use devices have long been known and used in the medical field and are packaged in sealed envelopes in order to maintain the sterility acquired by said devices after a sterilization treatment to which they are subjected after packaging.
When such devices are used, their particular structural characteristics must be able to preserve as much as possible the sterility characteristics of the entire device throughout administration to the patient.
Among such devices, some are used in particular administrations of a plurality of drugs in proportions which are predefined by doctors and which, in order to avoid endangering the patients, must keep the proportions strictly invariant.
A specific example of this type of device is the line of tubing and couplings used to perform angiographies by magnetic resonance, or magnetic-resonance diagnostic tests, in which it is necessary to use at least two injection syringes which are driven by a convenient presettable automatic device (injector); in a first step, each one of the syringes aspirates from a respective bottle containing contrast liquid for one syringe and physiological solution for the other syringe in calculated amounts; in a second step, the syringes inject the liquid and the solution into the patient by means of convenient tubes which are part of the single-use device.
Such device requires maximum attention on the part of assigned operators during the handling required to provide the several connections, since in addition to preventing external contaminations it is absolutely indispensable to avoid errors in mutually connecting the components due to evident patient safety reasons.
Currently, the devices used to perform these therapies have no barriers which can practically avoid the possibility of operator error in connecting both the ends of the tubes which enter the bottles with convenient piercing elements and the opposite ends which lead into the combined manifold tube leading to the syringes of the injector.
The aim of the present invention is to solve the above-noted drawbacks of the prior art by providing a single-use preassembled medical device for administering at least two drugs in preset proportions to patients, which first of all ensures maximum safety in the administration by preventing, with absolute safety, the operators from performing incorrect connections between the connection tubes, between the bottles that contain the drugs or the like, and the patient, and of the means adapted to administer the drugs, i.e. the syringes of the injector, and further ensures the sterility of the device and of the bottles connected thereto and of their contents, since once they are opened they are subject to likely contaminations, with the easily imaginable severe consequences for the patients after the first withdrawal.
This aim and other objects which will become better apparent hereinafter are achieved by a single-use preassembled medical device for administering at least two drugs in preset proportions to patients, comprising at least one pair of independent injector means and at least one pair of piercing couplings for corresponding bottles containing said drugs which are mutually connected by means of corresponding tubes leading into a single tube for infusion to a patient, characterized in that at least one of said piercing couplings forms a small cup-shaped receptacle for precision insertion of the neck of a bottle of a preset drug having correspondingly small dimensions.